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- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT01948167
Bending Adolescent Depression Trajectories Through Personalized Prevention
2 de março de 2021 atualizado por: Children's Hospital of Philadelphia
Investigators will combine risk factor research and evidence-based prevention programs, to advance knowledge on personalized approaches to prevention that may be able to better "bend trajectories" of depression that surge throughout adolescence.
Visão geral do estudo
Status
Concluído
Condições
Descrição detalhada
Investigators will innovatively combine risk factor research and evidence-based prevention programs, to advance knowledge on personalized approaches to prevention that may be able to better "bend trajectories" of depression that surge throughout adolescence.
A randomized controlled trial will examine the benefits of matching youth to two depression prevention programs of Interpersonal Psychotherapy-Adolescent Skills Training (IPT-AST) and Coping with Stress (CWS) for the prevention of depression in adolescents.
These two programs are designed to address distinct risk factors for depression - CWS addresses cognitive risks and IPT-AST addresses interpersonal risks.
A total of 210 participants across two sites, University of Denver and Rutgers University, will be stratified on cognitive and interpersonal risk and randomized to the two conditions.
The goals of the study are to (1) demonstrate that prevention programs can modify depression trajectories among youth by examining within person changes in trajectories over time (three years before and three years after the prevention programs) and by comparing trajectories of prevention youth with changes in same aged cohorts; (2) evaluate a personalized prevention approach to bending depression trajectories by matching and mismatching youth to either CWS or IPT-AST based on individual risk profiles; (3) examine mechanisms of bending depression trajectories and test whether the prevention programs operate via their hypothesized processes; and (4) explore how genetic susceptibility, emotion regulation, and temperament may affect individual response to IPT-AST and CWS.
By implementing evidence-based prevention programs after 3-years of prospective naturalistic data collection, this study will contribute essential data on personalized medicine and altering developmental trajectories of first-onset depression.
Tipo de estudo
Intervencional
Inscrição (Real)
205
Estágio
- Não aplicável
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
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Colorado
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Denver, Colorado, Estados Unidos, 80208
- University of Denver
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Illinois
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Champaign, Illinois, Estados Unidos, 61820
- University of Illinois Urbana Champaign
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New Jersey
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Piscataway, New Jersey, Estados Unidos, 08854
- Rutgers University
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Pennsylvania
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Philadelphia, Pennsylvania, Estados Unidos, 19146
- Children's Hospital of Philadelphia
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
12 anos a 17 anos (Filho)
Aceita Voluntários Saudáveis
Não
Gêneros Elegíveis para o Estudo
Tudo
Descrição
Inclusion Criteria:
- Currently in the 6th to 11th grades
- Adolescent and parent must be English-speaking
- Parental consent and adolescent consent
Exclusion Criteria:
- Presence of current Major Depressive Disorder, dysthymia, bipolar disorder, or significant psychosis
- Suicide attempt in the past week or significant suicidal ideation in the past week
- Presence of significant psychopathology or significant pervasive developmental delays that would make the group inappropriate
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Prevenção
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Experimental: Interpersonal Psychotherapy- Adolescent Skills Training
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A group prevention program that includes a 60-minute pre-group session, 8 weekly 90-minute group sessions, a 60-minute mid-group session, and 3 60-minute booster sessions.
IPT-AST focuses on psychoeducation and interpersonal skill-building to decrease interpersonal conflict and increase interpersonal support and competence.
Outros nomes:
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Experimental: Coping with Stress
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A group prevention program that consists of 8 acute 90-minute group sessions, 2 parent group sessions, and 3 continuation sessions lasting 60 minutes each.
Participants are taught to apply cognitive techniques to their personal thoughts, with the goal of generating effective counterarguments to unrealistic negative beliefs.
Outros nomes:
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Presence of a Major Depressive Episode or Dysthymia on the Schedule for Affective Disorders for School Aged Children - Present and Life Time Version (K-SADS-PL)
Prazo: Post intervention (approximately 3 months post baseline)
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Presence of a depression diagnosis as measured by a semi-structured diagnostic evaluation.
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Post intervention (approximately 3 months post baseline)
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Presence of A Major Depressive Episode or Dysthymia on the Schedule for Affective Disorders for School Aged Children - Present and Life Time Version (K-SADS-PL)
Prazo: 6-months post-intervention
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Presence of a depression diagnosis as measured by a semi-structured diagnostic evaluation.
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6-months post-intervention
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Presence of A Major Depressive Episode or Dysthymia on the Schedule for Affective Disorders for School Aged Children - Present and Life Time Version (K-SADS-PL)
Prazo: 12-months post-intervention
|
Presence of a depression diagnosis as measured by a semi-structured diagnostic evaluation.
|
12-months post-intervention
|
|
Presence of A Major Depressive Episode or Dysthymia on the Schedule for Affective Disorders for School Aged Children - Present and Life Time Version (K-SADS-PL)
Prazo: 18-months post-intervention
|
Presence of a depression diagnosis as measured by a semi-structured diagnostic evaluation.
|
18-months post-intervention
|
|
Presence of A Major Depressive Episode or Dysthymia on the Schedule for Affective Disorders for School Aged Children - Present and Life Time Version (K-SADS-PL)
Prazo: 24-months post-intervention
|
Presence of a depression diagnosis as measured by a semi-structured diagnostic evaluation.
|
24-months post-intervention
|
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Presence of A Major Depressive Episode or Dysthymia on the Schedule for Affective Disorders for School Aged Children - Present and Life Time Version (K-SADS-PL)
Prazo: 30-months post-intervention
|
Presence of a depression diagnosis as measured by a semi-structured diagnostic evaluation.
|
30-months post-intervention
|
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Presence of A Major Depressive Episode or Dysthymia on the Schedule for Affective Disorders for School Aged Children - Present and Life Time Version (K-SADS-PL)
Prazo: 36-months post-intervention
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Presence of a depression diagnosis as measured by a semi-structured diagnostic evaluation.
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36-months post-intervention
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Children's Depression Inventory (CDI)
Prazo: Post intervention (approximately 3 months after baseline)
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Self-reported depression scores
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Post intervention (approximately 3 months after baseline)
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Children's Depression Inventory (CDI)
Prazo: 6-months post-intervention
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Self-reported depression scores
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6-months post-intervention
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Children's Depression Inventory (CDI)
Prazo: 12-months post-intervention
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Self-reported depression scores
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12-months post-intervention
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Children's Depression Inventory (CDI)
Prazo: 18-months post-intervention
|
Self-reported depression scores
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18-months post-intervention
|
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Children's Depression Inventory (CDI)
Prazo: 24-months post-intervention
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Self-reported depression scores
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24-months post-intervention
|
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Children's Depression Inventory (CDI)
Prazo: 30-months post-intervention
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Self-reported depression scores
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30-months post-intervention
|
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Children's Depression Inventory (CDI)
Prazo: 36-months post-intervention
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Self-reported depression scores
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36-months post-intervention
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Children's Global Assessment Scale (CGAS)
Prazo: Post Intervention (approximately 3 months following baseline)
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Assesses global functioning
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Post Intervention (approximately 3 months following baseline)
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Children's Global Assessment Scale (CGAS)
Prazo: 6-months followup
|
Assesses global functioning
|
6-months followup
|
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Children's Global Assessment Scale (CGAS)
Prazo: 12-months followup
|
Assesses global functioning
|
12-months followup
|
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Children's Global Assessment Scale (CGAS)
Prazo: 18-months followup
|
Assesses global functioning
|
18-months followup
|
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Children's Global Assessment Scale (CGAS)
Prazo: 24-months followup
|
Assesses global functioning
|
24-months followup
|
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Children's Global Assessment Scale (CGAS)
Prazo: 30-months followup
|
Assesses global functioning
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30-months followup
|
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Children's Global Assessment Scale (CGAS)
Prazo: 36-months followup
|
Assesses global functioning
|
36-months followup
|
Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Jami F Young, Ph.D., Children's Hospital of Philadelphia
Publicações e links úteis
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Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo
1 de setembro de 2013
Conclusão Primária (Real)
1 de agosto de 2019
Conclusão do estudo (Real)
1 de agosto de 2019
Datas de inscrição no estudo
Enviado pela primeira vez
18 de setembro de 2013
Enviado pela primeira vez que atendeu aos critérios de CQ
18 de setembro de 2013
Primeira postagem (Estimativa)
23 de setembro de 2013
Atualizações de registro de estudo
Última Atualização Postada (Real)
4 de março de 2021
Última atualização enviada que atendeu aos critérios de controle de qualidade
2 de março de 2021
Última verificação
1 de março de 2021
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 17-013831
- R01MH077178 (Concessão/Contrato do NIH dos EUA)
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